US · 21 CFR
US Code of Federal Regulations, 21 CFR (GMP)
Every section of Part 210 (general provisions) and Part 211 (finished pharmaceuticals CGMP) of Title 21 of the US Code of Federal Regulations, which set out the current good manufacturing practice for drugs, organised section by section. Unlike the other collections in this library, which are guidelines and standards, this collection is the legally binding regulation itself. Documents FDA issues as recommendations are in the 'FDA guidance documents' collection just before this one. Each section links directly to the official eCFR text. Always check the official source for the revision history and the latest version.
- 21 CFR 211.1 Scope.
- 21 CFR 211.3 Definitions.
- 21 CFR 211.22 Responsibilities of quality control unit.
- 21 CFR 211.25 Personnel qualifications.
- 21 CFR 211.28 Personnel responsibilities.
- 21 CFR 211.34 Consultants.
- 21 CFR 211.42 Design and construction features.
- 21 CFR 211.44 Lighting.
- 21 CFR 211.46 Ventilation, air filtration, air heating and cooling.
- 21 CFR 211.48 Plumbing.
- 21 CFR 211.50 Sewage and refuse.
- 21 CFR 211.52 Washing and toilet facilities.
- 21 CFR 211.56 Sanitation.
- 21 CFR 211.58 Maintenance.
- 21 CFR 211.63 Equipment design, size, and location.
- 21 CFR 211.65 Equipment construction.
- 21 CFR 211.67 Equipment cleaning and maintenance.
- 21 CFR 211.68 Automatic, mechanical, and electronic equipment.
- 21 CFR 211.72 Filters.
- 21 CFR 211.80 General requirements.
- 21 CFR 211.82 Receipt and storage of untested components, drug product containers, and closures.
- 21 CFR 211.84 Testing and approval or rejection of components, drug product containers, and closures.
- 21 CFR 211.86 Use of approved components, drug product containers, and closures.
- 21 CFR 211.87 Retesting of approved components, drug product containers, and closures.
- 21 CFR 211.89 Rejected components, drug product containers, and closures.
- 21 CFR 211.94 Drug product containers and closures.
- 21 CFR 211.100 Written procedures; deviations.
- 21 CFR 211.101 Charge-in of components.
- 21 CFR 211.103 Calculation of yield.
- 21 CFR 211.105 Equipment identification.
- 21 CFR 211.110 Sampling and testing of in-process materials and drug products.
- 21 CFR 211.111 Time limitations on production.
- 21 CFR 211.113 Control of microbiological contamination.
- 21 CFR 211.115 Reprocessing.
- 21 CFR 211.122 Materials examination and usage criteria.
- 21 CFR 211.125 Labeling issuance.
- 21 CFR 211.130 Packaging and labeling operations.
- 21 CFR 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
- 21 CFR 211.134 Drug product inspection.
- 21 CFR 211.137 Expiration dating.
- 21 CFR 211.142 Warehousing procedures.
- 21 CFR 211.150 Distribution procedures.
- 21 CFR 211.160 General requirements.
- 21 CFR 211.165 Testing and release for distribution.
- 21 CFR 211.166 Stability testing.
- 21 CFR 211.167 Special testing requirements.
- 21 CFR 211.170 Reserve samples.
- 21 CFR 211.173 Laboratory animals.
- 21 CFR 211.176 Penicillin contamination.
- 21 CFR 211.180 General requirements.
- 21 CFR 211.182 Equipment cleaning and use log.
- 21 CFR 211.184 Component, drug product container, closure, and labeling records.
- 21 CFR 211.186 Master production and control records.
- 21 CFR 211.188 Batch production and control records.
- 21 CFR 211.192 Production record review.
- 21 CFR 211.194 Laboratory records.
- 21 CFR 211.196 Distribution records.
- 21 CFR 211.198 Complaint files.
- 21 CFR 211.204 Returned drug products.
- 21 CFR 211.208 Drug product salvaging.
